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YY/T 1534-2017 in English

YY/T 1534-2017 in English

VALID

Measuring methods for optical radiation safety classification of medical LED equipment

  • Issued on:2017-03-28
  • Implemented on:2018-04-01
  • File Format:PDF
  • Delivery:Via email within 1~3 business days
Price(USD): $160.00
$156.00
Standard No: YY/T 1534-2017
Document status: VALID
Title in English: Measuring methods for optical radiation safety classification of medical LED equipment
Title in Chinese: 医用LED设备光辐射安全分类的检测方法
Language: English
File Format: Electronic (PDF)
Delivery: Via email within 1~3 business days
Issued on: 2017-03-28
Implemented on: 2018-04-01
ICS Classification: 11.040.99-Other medical equipment
Professional Classification: YY-Pharmaceutics
Related Keywords: optical radiation safety classification
medical led equipment
optical radiation safety
medical led equipment introduction interpretation
testing equipment
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yy1534-2017
yy/t 1534
yy/t 1534-2017

本标准规定了波长范围在200nm到3000nm之间、具有一个或多个光源的医用LED设备的光辐射安全检测方法。
本标准适用于医用LED设备。
本标准不适用于眼科仪器、婴儿光疗设备。


Introduction

Interpretation of the core content of the standard

This standard establishes a systematic detection system for the optical radiation safety of medical LED equipment. The main technical points include:

Technical dimensions Key requirements Detection methods
Wavelength range 200-3000nm Measurement by wavelength
Classification basis IEC60601-2-57 risk group Comparison of achievable emission values
Core parameters Irradiance/Radiance Direct/Indirect Measurement Methods

In-depth Analysis of Measurement Technology

1. Irradiance Measurement Specifications

Using a 7mm aperture diaphragm, the field of view diaphragm size is calculated according to the formula F=α×r+D, where α is fixed at 1.4rad. Principles for selecting measurement positions:

  • Divergent light source: the point closest to human contact
  • Convergent light source: at the convergence point
  • Collimated light source: any point on the optical axis

2. Innovation in radiance measurement

Determine the measurement parameters by the apparent light source subtending angle (α=1.7-100mrad):

Case: The spot size of a tubular light spot (20mm long × 3mm diameter) is taken as the average value (20+3)/2=11.5mm


Suggestions for the implementation of the standard

  1. Laboratory configuration: Testing equipment that complies with Appendix B of GB/T 20145-2006 is required
  2. Personnel protection: Protective glasses and other equipment must be equipped, and the ambient illumination is <0.5lx
  3. Measurement process: Preheat for 30 minutes → Determine the maximum emission position → Gradual measurement (starting from Class 0 hazards and verifying step by step)

Multi-light source processing principle

When multiple light sources act on the same part, it must meet the following requirements: ∑(E/L)i/Limiti≤1. In practical applications, it should be noted that:

  • Light sources used asynchronously are evaluated separately
  • Light sources of different hazard types are not calculated superimposed

Sample only — not a preview of YY/T 1534-2017
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